Jaishankar Kutty, PhD

Vice President of Cardiovascular Therapies CoE

​Jaishankar (Jai) Kutty, Ph.D. brings 17+ years of multidisciplinary experience to the cardiovascular and structural-heart space, spanning R&D, Notified Body leadership, global clinical strategy, regulatory policy, and reimbursement-aligned evidence generation. He has helped deliver 100+ worldwide approvals, designed studies that de-risk innovation, and pushed the medtech industry to rethink how evidence should be built, validated, and leveraged. At RQM+, Jai leads regulatory, reimbursement, and clinical-evidence strategy for a global portfolio of next-generation cardiovascular technologies. Previously at BSI, he helped write the playbook for MDR clinical expectations and partnered closely with FDA, CA authorities, and Notified Bodies. A frequent speaker, writer, and RQM+ Live! panelist, Jai is known for his ability to take the snarled intersection of regulation, clinical science, and payer expectations, and make it understandable, strategic, and, occasionally, entertaining.